SPANISH NATIONAL REGISTRY OF BELIMUMAB IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

BackgroundBelimumab (BLM) is a monoclonal antibody that inhibits B-lymphocyte stimulating factor (BlyS) approved as a specific treatment for systemic lupus erythematosus (SLE) in 2011. We present the experience with BLM in a Spanish cohort with more than 460 patients.ObjectivesTo describe demographic characteristics, efficacy and safety of BLM in patients with SLE in Spanish population since its approval.MethodsDescriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011-2022). Demographic features, efficacy, laboratory variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed. To see whether a trend in BLM prescription had changed or not over time, two periods of time were analyzed: 2011-2016 (period1) and 2017-2022 (period2).ResultsBaseline characteristics of patients are summarized in Table 1.A total of 462 patients (36 hospitals) were included, 50.9% were on intravenous (IV), 34% on subcutaneous (SC) and 15.1% switched from IV to SC route. The median number of pre-BLM csDMARD use was 2.0 (2.0-3.0), being hydroxychloroquine (HCQ) the most frequently used (94.5%). Fifty-two patients were treated with IV cyclophosphamide with a median of 6 bolus received. At the time of BLM start, 443 patients were on prednisone with a median dose of 6.2 mg (5.0-10.0). Significant decreases in prednisone dose, SLEDAI and anti-DNA antibodies were observed from baseline until the last visit, whereas complement C3 and C4 values raised (Figure 1). A total of 118 patients (27.4%) had renal involvement with a median proteinuria of 1.0 g/day (0.5-2.4). Renal biopsy was done in 102 out of 118 patients, being class IV (33%), class III (21%) and class V (16%) the most frequently reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1-0.7).In period1, 100 patients started BLM compared to 362 in period2. The median time from SLE diagnosis to BLM begin was 7.1 (4.0-13.7) and 6.2 (2.1 -14.4) years in period1 and period2, respectively (p=0.454). We found a trend to use more csDMARD before BLM treatment in period1: 2.5 (2-3) vs. 2 (2-3) (p=0.088).A total of 143 (30.5%) patients discontinued treatment mostly due to inefficacy (55.9%) and infections (11.9%). In fact, 116 patients developed infections, mostly mild;2 patients died, 16 had COVID-19 and 4 patients developed tumors requiring discontinuation of the drug.ConclusionIn our cohort of SLE patients in a real-world setting, BLM has been effective, safe and seems to be a good choice to treat renal involvement.References[1]Navarra SV, Guzmán RM, Gallacher AE, et al. Lancet. 2011;377(9767):721-31.[2]Stohl W, Hiepe;rt al. Arthritis Rheum. 2012;64(7):2328-37.[3]Furie R, Rovin BH, Houssiau F, et al. N Engl J Med. 2020;383(12):1117-1128.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

USEFULNESS of AN ELECTRONIC CONSULTATION SYSTEM between PRIMARY CARE HEALTH CENTERS and RHEUMATOLOGY DEPARTMENT of A TERTIARY HOSPITAL

Background: The EPISER study is the frst Spanish epidemiological study that has confrmed the great burden of rheumatic diseases in the general population: they consume a large quantity of health resources (doctor visits, medical products) and imply a high social impact in terms of work absenteeism. Rheumatic diseases represent almost 30% of Primary Care medical consultations in Spain1,2. Electronic consultation could be an alternative response to the increase of this demand, both to make an early diagnosis and derivation and to improve communication with Primary Care physicians3,4. Objectives: To analyze the demand of Primary Care and its resolution through the electronic consultation system of the Rheumatology Department of a tertiary hospital. Methods: Retrospective descriptive study of the data collected in the request and information system (Sistema de Peticiones Electrónicas, SIPE) that supports electronic consultation between primary care physicians of the health area and the Rheumatology Department of a tertiary hospital, between July 2020 and May 2021.The following variables were collected: age, sex, reason for consultation, response time in days and destination (primary care/outpatient follow-up). Descriptive statistics were used to present the results. Results: The last 500 consecutive electronic consultations registered in the system, referring to 496 patients, were collected. Mean age was 59.5±17.7 years;74.2% women. Mean response time was 2 days, median response time 1 day and range 0-45. The reasons for consultation (see Graph 1) were: osteoporosis assessment 55 (11%), treatment adjustment 50 (10%), appointment request 49 (9.8%), loss to follow-up 43 (8.6%), local-regional pathology assessment 39 (7.8%), infltration request 28 (5, 6%), suspected rheumatoid arthritis 19 (3.8%), fare 18 (3.6%), suspected polymyalgia rheumatica or giant cell arteri-tis 16 (3.2%), COVID vaccine consultation 14 (2.8%), Raynaud's phenomenon 13 (2.6%), monoarthritis assessment 12 (2.4%), assessment of polyarthritis 11 (2.2%), adverse effects of treatment 11 (2.2%), suspected spondyloarthritis 11 (2.2%), suspected psoriatic arthritis 8 (1, 6%), generalized pain 7 (1.4%), suspected Sjögren's syndrome 5 (1%), suspected systemic lupus erythematosus 1 (0.2%), suspected other systemic autoimmune diseases 9 (1.8%), others 81 (16.2%). Fifty-seven and four % (287) of the patients required an appointment at the Rheumatology outpatient clinic and in 42.6% of the patients (213) the electronic consultation was successful, so it was not necessary to refer the patient to the hospital. Conclusion: Forty-two and six percent of the queries were resolved thanks to the electronic consultation system in an average of two days, otherwise that patients would have been referred to specialized care. The main reasons for consultation were osteoporosis assessment and clarifcation of doubts about the treatment of patients who were already being followed up by the Rheumatology Department.

Safety and efficacy of anakinra in severe SARS-CoV2 infection (covid19) at a tertiary hospital

Background: SARS-CoV-2 virus is a novel coronavirus that causes COVID-19 disease, which in its most severe form produces life-threatening atypical pneumonia and ARDS. Coronaviruses induce dysregulation of the immune system resulting in a cytokine storm syndrome with activation of the macrophage mediated mainly by IL-1 and IL-6. Although there is no specific treatment to date, researchers have explored novel approaches through targeting both IL-6 and IL-1. Anakinra is a recombinant human IL-1 receptor antagonist that prevents IL-1β and IL-1α binding and therefore blocks signal transduction. Its high bioavailability, rapid action, relatively short half-life and good safety profile make it a promising drug. Objectives: Analyse the experience of administering Anakinra for severe forms of COVID19 in patients hospitalised at a tertiary hospital. Methods: Retrospective single-center study in which all patients admitted for COVID-19 and treated with Anakinra from April 1st to the end of the 1st wave (July 2020) were included. Medical records were reviewed to collect demographic, clinical and lab test data, using Brescia-COVID respiratory severity scale, SaFi, CRP, Ferritin, LDH and lymphocytes. Variables were assessed at baseline, 72h and 7 days after treatment initiation. Descriptive statistical analysis was performed, including a sub-analysis of patients who received anakinra as the only biological treatment. Results: 54 patients were included, of which 37 male (68.5%) with a median age of 69.5 years (36-94). Comorbidities were lung disease 14 pts (25.9%), cardiovascular disease 39 pts (72.2%), Diabetes Mellitus 11 pts (20.4%), kidney disease and rheumatic disease each in 6 pts (11.1%), and immunosuppression 13 pts (24.1%). Each patient received a mean of 4.85 doses of anakinra (± 3.96). Other therapies included low-dose steroids (70.3%);high-dose steroids: 1mg/kg (87%), bolus (24%), Tocilizumab (57.4%), Infliximab (24.1%), Lopinavir/Ritonavir (48%), Hydroxychloroquine (94.4%), and Azithromycin (79.6%). Mortality was 22% overall, 75% due to COVID19, 8.3% due to infectious complications and 16.7% due to non-infectious complications. In the group receiving Anakinra as only biological drug, mortality accounted for 17.9% of patients, 75% due to COVID19 and 25% to non-infectious complications. No adverse effects related to anakinra were observed Conclusion: Anakinra in severe SARS-CoV-2 infection offers respiratory improvement and partial lab tests improvement. No adverse effects were observed.